Stryker PEEK Customized Implant: A Prospective Post Market Follow Up to Evaluate Safety, Performance and Effectiveness

Last updated: June 11, 2025
Sponsor: Stryker Craniomaxillofacial
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

Treatment

Stryker's PEEK Customized Implant

Clinical Study ID

NCT05362370
CMF_2021_01
  • Ages > 42
  • All Genders

Study Summary

The purpose of this study is to confirm the safety, performance and effectiveness of Stryker's PEEK Customized Implants when used for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton. The study is designed as a prospective, multi-center trial with a long-term follow-up (24 months) of study participants.

Eligibility Criteria

Inclusion

Inclusion Criteria

  1. Subject is eligible for a PEEK customized implant as per routine clinical practice.

  2. Subject is 12 years of age or older (Europe only).

  3. Subject is 3.5 years of age or older (USA only).

  4. Adult subjects able to give consent.

  5. Subjects under the age of 18 will have a legal representative or parents (France - both parents must sign) to provide informed consent.

  6. Subjects who are unable to give consent themselves but have a legally authorized representative that may consent on their behalf.

Exclusion Criteria

  1. Subject has an active systemic or local infection.

  2. Subject has known allergy to plastic or polymers and/or known sensitivity to foreign bodies.

  3. Comprised bone due to poor blood supply, disease, infection or prior implantation, which would not allow adequate support or fixation of the implant.

  4. Mental or neuromuscular disorder which could create an unacceptable risk of implant instability or implant fixation failure, or complications in postoperative care.

  5. Knowingly pregnant or nursing women.

  6. Concomitant participation in other clinical trials related to cranioplasty.

  7. Subject who has an expected survival rate of less than 2 years, in the opinion of the investigator who takes consent.

Study Design

Total Participants: 110
Treatment Group(s): 1
Primary Treatment: Stryker's PEEK Customized Implant
Phase:
Study Start date:
February 01, 2023
Estimated Completion Date:
December 30, 2027

Study Description

Stryker's PEEK Customized Implants are patient-specific implants based on CT-data of the individual patient and input of the surgeon. The implants are fabricated from Polyetheretherketone (PEEK) and intended to be used to fill bony voids in the cranial and craniofacial region (e.g. cranium, orbital rim, zygoma, and adjacent bone). This observational post-market clinical follow-up (PMCF) is designed to confirm the safety, performance and clinical benefit of Stryker's PEEK Customized Implants for the augmentation and/or restoration of bony and/or soft tissue deformities in the cranial and craniofacial skeleton (orbital rim, zygoma, and adjacent bone); including but not limited to, the correction and prevention of persistent temporal hollowing (PTH). Infection of implants is one of the common risks associated with this type of surgery. This PMCF study will investigate infection rate as the primary safety endpoint. These data will be collected in a real world setting, where all treatment is per routine clinical practice. The study is designed as a prospective, multi-center trial at participating institutions in the United States and in Europe. Up to 110 study participants will be enrolled in this PMCF. Stryker's PEEK Customized Implants are intended to stay implanted permanently. Therefore, study participants will be followed for 24 months after implantation of the devices to allow evaluation of long-term safety and performance of the products.

Connect with a study center

  • Universitätsklinik für Neurochirurgie Auenbruggerplatz 29

    Graz, 8036
    Austria

    Active - Recruiting

  • Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9

    Toulouse, Occitanie TSA 40031 - 31059
    France

    Active - Recruiting

  • APHP - Hôpital Lariboisière Neurochirurgie 2 rue Ambroise Paré

    Paris, Paris France 75010
    France

    Active - Recruiting

  • CHU Nantes - Hopital Guillaume et Rene Laënnec, Cedex 1

    Nantes, Pays de la Loire 44093
    France

    Site Not Available

  • Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240

    Dortmund, Nordrhein-Westfalen 44145
    Germany

    Active - Recruiting

  • St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 | 1263

    Hamm, 59073
    Germany

    Active - Recruiting

  • Servicio de Neurocirugía Hospital Universitario La Paz.

    Madrid, 28046
    Spain

    Active - Recruiting

  • Neurosurgery, Emergency and Major Trauma (NET) Research | Division of Medicine | Imperial College Healthcare NHS Trust

    London, SW7 2AZ
    United Kingdom

    Active - Recruiting

  • University of Louisville 501 E. Broadway, Suite 210

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Department of Neurological Surgery

    New Brunswick, New Jersey 07101-1709
    United States

    Site Not Available

  • Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital

    New York, New York 10032
    United States

    Active - Recruiting

  • Lewis Katz School of Medicine at Temple University, 3401 North Broad Street

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • Medical University of South Carolina, Oral & Maxillofacial Surgery, 173 Ashley Avenue, Charleston, USA

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

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